A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
NCT ID: NCT05927571
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
120 participants
INTERVENTIONAL
2023-08-10
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Safety Lead-In Cohort
Participants will receive cevostamab, intravenously (IV), in combination with elranatamab, subcutaneously (SC), with step-up dosing of each drug in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.
Cevostamab
Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
Elranatamab
Elranatamab solution for injection will be administered SC as specified in each treatment arm.
Tocilizumab
Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Dose Expansion Cohort (Combined Therapy)
Participants will receive cevostamab, IV, in combination with elranatamab, SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.
Cevostamab
Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
Elranatamab
Elranatamab solution for injection will be administered SC as specified in each treatment arm.
Tocilizumab
Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Dose Expansion Cohort (Monotherapy)
Participants will receive elranatamab SC, with step-up dosing in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity.
Elranatamab
Elranatamab solution for injection will be administered SC as specified in each treatment arm.
Interventions
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Cevostamab
Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
Elranatamab
Elranatamab solution for injection will be administered SC as specified in each treatment arm.
Tocilizumab
Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of R/R MM per IMWG criteria
* For female participants of childbearing potential: agreement to remain abstinent or use contraception
* For male participants: agreement to remain abstinent or use a condom
Exclusion Criteria
* Prior treatment with elranatamab
* Prior allogeneic stem cell transplantation (SCT)
* Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells
* Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome
* Participants with known history of amyloidosis
* History of autoimmune disease
* History of confirmed progressive multifocal leukoencephalopathy
* Peripheral motor polyneuropathy of prespecified grade
* Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection
* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
* Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Human immunodeficiency virus (HIV) seropositivity
* History of central nervous system (CNS) myeloma disease
* Significant cardiovascular disease
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
The Alfred Hospital
Prahan, Victoria, Australia
Rambam Health Care Campus
Haifa, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Sheba Medical Center - PPDS
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, , Israel
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Seocho, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center - PPDS
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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2023-504657-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
GO43979
Identifier Type: -
Identifier Source: org_study_id
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